Better Antibodies By Design - Jefferies 1120 3 Genmab.pdf · Better Antibodies By Design Jefferies 2014 Global Healthcare Conference November 20, 2014

Better Antibodies By Design

Jefferies 2014 Global Healthcare Conference

November 20, 2014

Forward Looking Statement

This presentation contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and

similar expressions identify forward looking statements. All statements other than statements of historical facts included in

this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives

of management for future operations (including development plans and objectives relating to our products), are forward

looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which

may cause our actual results, performance or achievements to be materially different from any future results, performance or

achievements expressed or implied by such forward looking statements. Such forward looking statements are based on

numerous assumptions regarding our present and future business strategies and the environment in which we will operate in

the future. The important factors that could cause our actual results, performance or achievements to differ materially from

those in the forward looking statements include, among others, risks associated with product discovery and development,

uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety

issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of

market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business

area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of

our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which

may render our products obsolete, and other factors. Further, certain forward looking statements are based upon

assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak

only as at the date of this presentation.

2

Antibody Innovation Generating World Class Products

Focus on Cancer

• Differentiated human antibodies

• Track record breakthrough therapeutics

Robust Product Pipeline

• Ofatumumab – cancer & autoimmune potential (marketed as Arzerra® in various CLL indications)

• Daratumumab blockbuster potential

• HuMax®-TF-ADC in Phase I solid cancers

Passion for Innovation

• World class antibody know-how• Proprietary technologies – DuoBody® & HexaBody™• Innovative pre-clinical pipeline

Partnerships → Product Ownership

• Key collaborations drive current pipeline

• Product opt-ins + retain products for future value

• Well capitalized3

Product Disease IndicationsDevelopment Phase

Pre-

clinicalI I/II II III

Ofatumumab

17 studies

Target: CD20

Partner: GSK*

*Novartis to develop cancer

indications subject to asset

swap approval

Chronic lymphocytic leukemia (CLL)

Follicular lymphoma (FL)

Pemphigus vulgaris (PV)

Relapsing remitting multiple sclerosis (RRMS)

Neuromyelitis optica (NMO)

Daratumumab

9 studies

Target: CD38

Partner: Janssen

Multiple myeloma (MM)

HuMax-TF-ADC

Target: TF

Partner: Seattle

Genetics

Solid Cancers

Teprotumumab

2 studies

Target: IGF-1R

Partner: River Vision

Active thyroid eye disease

Diabetic macular edema

10 Active

Pre-clinical

programs incl.

HuMax-AXL-ADC

Partnered programs: HuMab, DuoBody & HexaBody

Proprietary programs: HuMab, HuMab-ADC,

DuoBody, DuoBody-ADC & HexaBody

Innovative Pipeline

4

Announced

Announced

• Targets CD38 - 5 different ways of attacking cancer cells

• Multiple Myeloma & other blood cancers

• Blockbuster potential

• Promising early clinical MM data

• Broad & expansive development in MM

• Breakthrough Therapy Designation

First-in-Class Fully Human Antibody

• Janssen funds development & commercialization

• > $1.1B potential deal value, + double-digit royalties

• Zero cost / limited financial risk for Genmab

Partner: Janssen Biotech

Daratumumab (HuMax®-CD38)First-in-Class Antibody with Broad-Spectrum Killing Activity

5

• ALL, AML, DLBCL, FL, Plasma Cell Leukemia, Mantle Cell Leukemia, CLL

Additional Potential Blood Cancer Indications

Indication Disease Stage Therapy

Development Phase

Pre-

clinicalI I/II II III IV

Multiple Myeloma

Front line

(transplant & non-

transplant)

Dara + VMP*

Dara + Revlimid + Dex*

Dara + VTD*

Multi combo: 1 Study

Relapsed or Refractory

Dara + Revlimid + Dex

2 Studies

Dara + Velcade + Dex

1 Study

Mono, Japan

Mono, safety

Double Refractory Mono, BTD population

Smoldering In planning

Maintenance Integrated into some study protocols

Non-MM Various

Potential in: ALL, AML,

DLBCL, FL, Plasma Cell

Leukemia, Mantle Cell

Lymphoma, CLL

Expansive Daratumumab Development 10 Ongoing or Announced Studies in Multiple Myeloma

6*Phase III study announced, not yet started.

Daratumumab: Early Signs of Clinical ActivityPhase I/II Monotherapy Study

• Relapsed and refractory multiple myeloma, ASCO 2014

• Safety & efficacy in 49 patients

• 35% response rate at 16 mg/kg

• Treatment well tolerated

7Data presented at ASCO 2014

Daratumumab: Early Signs of Clinical ActivityPh I/II Revlimid Combo Study in Multiple Myeloma

8

12/13 pts

= 92%

response

rateIncluding all

pts 15/20 =

75%

response

rate

Limited

treatment

Data presented ASCO 2014 Ph I/II relapsed / refractory

Arzerra® (ofatumumab)

• Fully human antibody targeting CD20 on cancerous B-cells

• Differentiated vs other CD20 mAb, targets slice of > $7B market

Cancer

• Approved*

• US 1st Line CLL in combo w/ chlorambucil

• EU 1st Line CLL in combo w/ chlorambucil or bendamustine

• Fludarabine and alemtuzumab refractory CLL

• 7** Phase III trials in CLL & FL

• Novartis potential partner 2015 (subject to GSK / Novartis deal close)

Autoimmune diseases (unapproved)

• Phase III trial ongoing in PV

• Relapsing remitting MS Ph IIIs & pivotal NMO trial announced

• Partnered with GSK

Our First Marketed Product

• 2013 sales GBP 74.9M (~$124M); royalty DKK 131M

• Genmab Cancer Royalty = 20%

Sales Growth by GSK

9

*In US approved in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate as well as

for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

In EU approved in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-

based therapy, as well as for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

**Source: clinicaltrials.gov

Transfer of Ofatumumab Collaboration from GSK to Novartis

• Existing ofatumumab collaboration to be

transferred to Novartis

• Novartis to develop ofatumumab in cancer

indications

• GSK to continue ofatumumab

development in autoimmune diseases

• No further Genmab funding beyond

December 2014

• Future cash impact of GBP 60 M (DKK

570 M)

• CD20 exclusivity provisions modified

• Agreement dependent on closing of wider

GSK-Novartis transaction

10

Arzerra Label Expansion: Phase III Data Ofatumumab + Chlorambucil Extends Progression Free Survival

• Ofa + chlorambucil vs.

chlorambucil in front line CLL

• 71% improvement in PFS

• No unexpected safety

findings - Most common

SAEs:

• Neutropenia (5%), anemia

(4%), pneumonia (4%)

and pyrexia (2%)

11

Ofatumumab: Planned & Ongoing Trials

Note: The indications above are unapproved

*Interim data reported

Relapsed CLL*O maintenance vs

observation

Relapsed CLLOFC vs FC

Refractory FLO+B vs B

Relapsed FLO mono vs R mono2

01

72

01

62

01

52

01

4 RRMS

Ph II monotherapy

PV

Ph III efficacy & safety

RRMS

multiple Ph III’s

NMO

pivotal study

On

go

ing

Pla

nn

ed

Cancer (IV)Pivotal Study Readouts

Autoimmune (SC)Ongoing & Planned

12

Ofatumumab: Potential to Combine with Tyrosine Kinase Inhibitors

13

Sources:

Da Roit et al. “Ibrutinib interferes with the cell-mediated anti-tumor activities of therapeutic CD20 antibodies: implications for combination therapy.” Abstract.

EHA 2014

Jaglowski et al. “A Phase Ib/II study evaluating activity and tolerability of the BTK inhibitor ibrutinib in combination with ofatumumab in patients with chronic

lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) and related diseases.” ASCO 2014

ADCC

TKIs knock out immune effector cells

(NK cells, macrophages) so ADCC ineffective

Ofatumumab most active CDC killing compared to other

CD20 mAb

Ibrutinib -ofatumumab

combination highly active in CLL, ISS

study at ASCO 2014

CDC

Relapsing Remitting Multiple Sclerosis (RRMS)

• Phase III’s in RRMS expected to begin in 2015

• Follow encouraging Phase II data

• Sustained reduction cumulative number new brain lesions over 12 week period

• No unexpected safety findings

• MS market forecast to peak at $18.5B in 2018*

Neuromyelitis Optica (NMO)

• GSK plans IND for potential pivotal study in NMO in 2014

• NMO, a rare autoimmune disorder

• No licensed therapy for NMO

• Orphan indication

Pemphigus Vulgaris (PV)

• Phase III study ongoing

• Orphan indication

Multiple Ph III Trials to Start in Autoimmune Indications

Ofatumumab - Future in Autoimmune

*Source: Datamonitor “Multiple Sclerosis Forecast” 2014. Incl. US, Japan & 5 major EU 14

HuMax®-TF-ADC: In the ClinicNext Generation Therapeutics

• Targets Tissue Factor (TF)

• Strong pre-clinical data in multiple solid cancers

• Ongoing Phase I study

• Collaboration: Seattle Genetics opt-in (after Ph I/II)

Fully Human Antibody-drug Conjugate

Pre-clinical Cervical Cancer Model

15

• Ovary, cervix, endometrium, bladder, prostate, head & neck, esophagus, lung

• Potential also in pancreatic cancer

8 Tumors

DuoBody® Technology Efficient & Versatile Platform for Bispecific Antibodies

• Dual-targeting, potential to improve specificity & efficacy

• Large scale manufacturing

• Minimal protein engineering

• Excellent quality BsAb at very high yields

• Differentiated from competitor platforms

• Proper in vivo half-life

• Fc-effector functions

• Good manufacturability

DuoBody

• 2 Commercial deals

• Novartis (2 programs, $175M potential deal value + royalties)

• Janssen Biotech (20 programs, $3.6B potential deal value + royalties)

• 7 Research deals

• Lilly, Kirin, Cormorant, undisclosed major Biotech, Agenus, BioNovion, Humabs BioMed

Ongoing Collaborations

16

HexaBody™ Technology Robust Effector Function Enhanced Antibodies

• Enables antibodies to more readily form clusters of 6 (hexamers)

• Induces & enhances target cell killing after binding via CDC

• CDC capability to essentially any antibody

• Builds on natural antibody biology - minimal engineering

• Create novel, differentiated products in cancer & infectious disease

• Repurpose / rescue drug candidates that failed in Phase II/III

• Life cycle management

• Collaborations with undiscl. major Biotech & Humabs BioMed

HexaBody

17

Op

t-in

s

Part

ners

hip

s

Lic

en

sin

g

Ow

ne

rsh

ipValue inflection

Greater rewards

Greater value after PoC

Creates sustainable company

Exchange for technology

Many shots on goal

Products / Technology

Validation

Creating Value With Our Technologies

Janssen DuoBody

Novartis DuoBody

Ofatumumab

Daratumumab

HuMax-TF-ADC

HuMax-AXL-ADC

Pipeline products

HuMax-TAC-ADC

DuoBody IL-8 + X

18

43%

14%

24%

6%

13%

2014 Expense BaseDKK 625M ($105M)

DevelopmentResearchSalaryDepreciation & WarrantsOther

Cash Position DKKM USDM*

Cash position

beginning of year**1,557 263

Cash used in

operations0 – (50) 0 - (8)

Proceeds from

private placement972 164

Warrant exercises 46 8

Cash position at

end of year**2,450 – 2,550 414 - 431

*USD 1.00 = DKK 5.9152

**Cash, cash equivalents and marketable securities

Well-Capitalized Biotech – 2014 Guidance

DKK 266M

($45M)

DKK 150M

($25M)

DKK 85M

($14M)

DKK 41M

($7M)DKK 83M

($14M)

Income Statement DKKM USDM*

Revenue 800 - 875 135 - 148

Operating expenses (600) – (650) (101) – (110)

Operating income 175 – 250 30 - 42

192014 Guidance – August 13, 2014

2014 Goals: Fueling Growth Through Our Platforms & Products

Priority Targeted Milestone

Maximize value of

ofatumumab

2015

X

X

» Ph III relapsed CLL ofa + FC data

» Ph III maintenance CLL data

» Ph III bulky refractory CLL ofa vs physician’s choice data

» Ph III relapsed DLBCL; ofa + chemo vs RTX + chemo data

» Update progress sc autoimmune development

Expansion Arzerra

» CLL front line label expansion and launch

» Launch & reimbursement in new countries

Fully exploit the

potential of

daratumumab

2015

» Ph I/II MM monotherapy matured efficacy data

» Ph I/II MM dara + Revlimid safety & efficacy data

» Ph II MM monotherapy preliminary data

» Ph Ib MM multi combo data

» Start multiple new MM trials

» Progress non-MM indications

Expand pipeline

» Progress Ph I HuMax-TF-ADC study

» Report progress pre-clin. ADC, DuoBody & HexaBody projects

Next generation

technologies

» Enter new DuoBody technology collaborations

» Report progress DuoBody collaborations

» Start HexaBody technology collaborations

Partnerships

» Report progress partnered programs

» Enter new collaboration

Disciplined

financial

management

» Significant daratumumab milestones

» No significant increase in cost base

» Increase operating income and reduce cash burn20

On Track to a Sustainably Profitable Future

21

• Robust differentiated product pipeline

• Daratumumab, ofatumumab, HuMax-TF-ADC

• Innovative pre-clinical pipeline

• Proprietary technologies -DuoBody & HexaBody

• Partnerships → Product ownership

• Well capitalized

• Positioned for success

• For patients & shareholders

Better Antibodies By Design